Device Recall Stryker

Lots: 96910501; 96949401; 96940901;  96950901.

Orthopedic Devices

1

No

The 9 units were sent out to 2 US branch/agents and one international distributor.

Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.

Part Number: 234-010-078, Lot # 32101;  Part Number: 234-010-080, Lot # 32103

Orthopedic Devices

2

Yes

6 consignees (locations to be determined) received 15 units. the remaining 147 units were distributed to international divisions.

Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm || Part Numbers: 234-010-078; 234-010-080

Model numbers 240-099-011- Serial numbers 031111001-021, 040114001-029, 040130001-007, 040308001-023, 040322001-010, 040412001-020. 240-099-012- serial numbers 040130008-022, 040311001-015, 040322001-010, 040401001, 002, 004 and 005. 240-099-020-serial numbers 040212001-032, 040309001-007, 040313001-010. 240-099-021-serial numbers 040224001-021, 040313017. 240-099-050-serial numbers 031218001-005, 031218031-045

General and Plastic Surgery Devices

2

No

The products were distributed to 114 consignees.

Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately.

The following part numbers and subsequent lot numbers are involved in this recall. Part number 0275-950-000: 04109232, 0419292, 04109312, 04119712, 04119732, 04363AG2, 04364AG2. Part number 0275-951-012: 04098532, 04098752, 04098852, 04098872, 04109172, 04109212, 04109292, 4109312, 04119352, 04119392, 04119432, 04119712, 04129892,04129912, 04355AG2, 04357AG2, 04358AG2, 04363AG2. Part number 0275-951-012S1: 4098812, 04119672. Part number 0275-951-200: 04098492, 04362AG2. Part number 0275-952-000: 04108972, 04113432, 04129812, 05013AG2. Part number 0375-950-000: 0409522, 04112882, 04112962, 04123162. Part Number 0975-950-012: 04102542, 04102662, 04123162, 04123202. Part number 0375-951-012: 04092262, 4092362, 04092402, 04112862, 04112882, 04112902, 04113042, 04113082, 04123142, 04123202. Part Number 0375-951-200: 04113042. Part number 0275-950-012: 04098812, 04108912, 04109152, 04119512, 0411612, 0411712, 04129792, 04357AG2. Part Number 0275-951-000: 04098532, 04098552, 04098752, 04098772, 04098832, 04098852, 04098892, 04108912, 04109152, 04109172, 04109192, 04109232, 04109252, 04109292, 04119412, 04119432, 04119612, 04119632, 04119712, 04119732, 04129792, 04129852, 04129912, 04129972, 04352AG2, 04352AG2. Part Number 0375-951-000: 04092262, 4092362, 04102542, 04102662, 04102682, 04102762, 04112882, 04113002, 04113082, 04123162, 04123202, 04123222. Part number 0375-952-000: 04092522, 04102602, 04113042, 04123222.

Orthopedic Devices

2

No

740 domestic consignees

Stryker Brand 5.5mm 6 Flute Barrel Bur, || Model Number: 375-951-000; || Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138

Lots 2005052002, 2005060703, 2005061401, 2005062001 and 2005063001.

General Hospital and Personal Use Devices

2

No

Nationwide, Australia and Canada.

Stryker PainPump1 2-Day Infusion Kit; Product number 500-120-000.